NCT01053832已完成不适用
Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
研究概览
简要总结
Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
详细描述
The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal AV block and/or Sinus Node Dysfunction
- •DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability
排除标准
- •Permanent AV block III°
- •Permanent Atrial Fibrillation/ Flutter
- •Require mode other than DDD(R)-ADI(R) or DDD(R)
- •Have a life expectancy of less than six months
- •Expected to receive heart surgery within six months
- •Enrolled in another cardiac investigation
研究组 & 干预措施
Ventricular Pace Suppression- ON
Other
干预措施: VpS algorithm in EVIA and ENTOVIS pacemakers (Device)
Ventricular Pace Suppression- OFF
Other
干预措施: VpS algorithm in EVIA and ENTOVIS pacemakers (Device)
结局指标
主要结局
Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.
时间窗: 6-8 months
次要结局
- A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.(6-8 months)
研究者
研究点 (2)
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